Catalog Number

CL-N2O-8G-UNBOX

Brand Name

Freezpen®

Version/Model Number

8g cartridges for Freezpen

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K024009,K024009,K024009

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

6d4bf3e6-3864-4beb-b4d7-d2948ec528ef

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Package DI Number

25407008484105

Quantity per Package

16

Contains DI Package

15407008484108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-